Industry Playbook

The Centre of Excellence for the Prevention of Organ Failure (PROOF Centre) has partnered with AstraZeneca and the Canadian Study of Prediction of Death, Dialysis, and Interim Cardiovascular Events (CanPREDDICT) to develop a blood test to predict the rate of disease progression in patients with chronic kidney disease (CKD). For the discovery phase of the project, PROOF Centre and AstraZeneca researchers will use the large cohort and extensive clinical data available from the CanPREDDICT study. The collective team of clinical, computational, technical, and biological experts will also use the PROOF Centre’s computationally-driven omics biomarker development pipeline to identify genomic and proteomic biomarkers that can discriminate between patients who have rapid versus slow CKD progression. Overall, the PROOF Centre will support the analysis from front-end experimental design to downstream statistical and biological analysis.

An effective prognostic test would enable clinicians to manage CKD more aggressively in patients expected to decline rapidly, potentially delaying end-stage renal disease. It could also potentially reduce healthcare costs by identifying stable or improving patients who require less frequent monitoring. Additionally, the partnering organizations believe that a prognostic CKD assay could be extremely valuable for research and drug development. "Knowing which patients with this disease are likely to face rapid decline and which ones are not is a major hurdle in clinical trials for new therapeutics,” said Peter Greasley, PhD, director of clinical research at AstraZeneca. “Biomarkers identified in this collaboration will enable patient stratification that in turn may reduce the time, number of patients, and costs needed for such trials.”

Qiagen Enters New Bioinformatics Agreements

Qiagen has formed new partnerships to enhance the profile and expand the use of its bioinformatics solutions for microbiome, metagenomics, and other applications. In the first of these collaborations, Qiagen Bioinformatics has signed an agreement with genomics big data company CosmosID. This will allow users of Qiagen’s CLC Genomics Workbench to access CosmosID’s metagenomics analysis platform and employ shotgun metagenomics analysis for routine testing involving next-generation sequencing.

Qiagen has also awarded a contract to its partner, Trigent Solutions, that will grant seven centers of the Food and Drug Administration (FDA) streamlined access to Qiagen’s bioinformatics solutions. The products made available to FDA centers include software for infectious diseases research and outbreak analysis, as well as solutions in human genomics. The contract also includes services that aim to combat infectious outbreaks by enabling the uploading and sharing of public health data with U.S. and international institutions via the National Center for Biotechnology Information’s Sequence Read Archive.

Illumina Acquires HLA Typing Company

Illumina recently bought Conexio Genomics, a company focused on human leukocyte antigen (HLA) typing, in order to advance its work developing next-generation sequencing (NGS) solutions for the HLA typing market. According to a press release from Illumina, Conexio’s innovations played a key role in kick-starting the sequencing era for HLA typing. Since then, Conexio has introduced a complete line of sample-to-report products for genotyping HLA genes with both Sanger sequencing and NGS. Conexio’s NGS development programs have been integrated into Illumina. This will enable Illumina to develop NGS-based transplant diagnostics assays, including a new solution for interrogating genomic variants in the gamma genomic block of the major histocompatibility complex.

Abbott Buys Alere to Expand POCT Offerings

Abbott has entered a definitive agreement to acquire Alere in order to advance its point-of-care testing portfolio. Upon completion of the transaction, the combined business will offer a broad point-of-care menu in infectious diseases, molecular, cardiometabolic, and toxicology testing, expanding Abbott’s platforms to include benchtop and rapid strip tests. Alere’s complementary portfolio of products will provide Abbott with access to new channels and markets, including entry into fast-growing outlets such as doctors’ offices, clinics, pharmacies, and at-home testing. Abbott’s capabilities and infrastructure will also drive accelerated growth of Alere’s portfolio, which has a rising presence in key international markets. Under the terms of the agreement, Abbott will pay $56 per common share at a total expected equity value of $5.8 billion, and Alere will become a subsidiary of Abbott. Abbott’s and Alere’s respective boards of directors have approved the transaction, which is now subject to the approval of Alere shareholders and the satisfaction of customary closing conditions.

Thermo Fisher, CHLA to Develop NGS Panel for Childhood Cancers

Thermo Fisher Scientific and Children’s Hospital Los Angeles (CHLA) are collaborating to develop a comprehensive next-generation sequencing (NGS)-based panel designed specifically for pediatric cancer research. With this assay, the two organizations aim to improve understanding of the pathogenesis and future therapy of pediatric cancer patients. Using as little as 10 ng of DNA and RNA from fixed, fresh, or frozen tumor tissue, the panel will detect virtually all somatic genetic alterations identified for childhood cancer to date in the scientific literature. This will include DNA mutations, gene amplifications, more than a thousand gene fusion variants, and more than a hundred tumor-specific gene translocations. The assay will use Thermo Fisher’s Ion Torrent NGS platform and Ion AmpliSeq technology. It builds on the experience and expertise of a team of laboratory research scientists and pathologists from CHLA’s Center for Personalized Medicine, and of clinicians and pediatric cancer investigators at CHLA’s Children’s Center for Cancer and Blood Diseases, which is home to one of the largest pediatric hematology-oncology programs in the country.

Sysmex, Eisai Partner on Blood Tests for Dementia

Sysmex Corporation and Eisai have joined forces to create next-generation diagnostics that will enable early diagnosis of dementia, while also improving selection of treatment options and the ability to monitor the effects of treatment. The partnership will build on Sysmex’s diverse expertise in the field of clinical diagnostics as well as the company’s technologies for detecting genetic, protein, and cellular biomarkers in blood samples. It will also leverage Eisai’s experience from more than 30 years of drug discovery work in the field of dementia. Under the terms of the agreement, Sysmex will lead the development of diagnostics and will exclusively market these tests worldwide after receiving regulatory approval. Eisai will receive payments for meeting development milestones and launching products, as well as royalties on sales, and will use these next-generation diagnostics for drug discovery and development in the field of dementia.